Low-risk palpable breast masses removed using a vacuum-assisted hand-held device

doi:10.1016/S0002-9610(03)00263-0

The American Journal of Surgery

Volume 186, Issue 4, October 2003, Pages 362-367

Presented at the Fourth Annual Meeting of the American Society of Breast Surgeons, Atlanta, Georgia, April 30–May 4, 2003

https://doi.org/10.1016/S0002-9610(03)00263-0 Get rights and content

Abstract

Background

This study evaluates the safety, efficacy, and patient acceptance of a vacuum-assisted, hand-held biopsy device (Mammatome) in the percutaneous removal of breast masses using ultrasound guidance.

Methods

A multicenter, nonrandomized study evaluated 216 women with low-risk palpable lesions. Lesions 1.5 to 3.0 cm in size were removed using an 8-gauge probe. Those lesions <1.5 cm were removed with the 11-gauge probe. Follow-up evaluation was performed at 10 days and 6 months after biopsy.

Results

A total of 127 patients had biopsies using the 8-gauge probe, and 89 patients had biopsies using the 11-gauge probe. At 6-month follow-up, 98% of the lesions remained nonpalpable, 73% with no ultrasonographically visible evidence of the original lesion. Most complications were mild and anticipated. Most patients (98%) were satisfied with incision appearance, and 92% of patients would recommend the procedure to others.

Conclusions

Percutaneous removal of palpable benign breast masses using the Mammotome system is feasible and safe, and yields high patient satisfaction. The results at 6 months after biopsy demonstrated the effectiveness of benign lesion removal, with correlative clinical data demonstrating lack of palpability and no need for additional procedures. Continuing evaluation of long-term efficacy is ongoing.

Section snippets

Methods

Thirty sites were recruited for the study, with 21 enrolling patients. Prior to the initiation of the study, principal and subinvestigators from each of the enrolling study sites underwent a 1-day procedural standardization session (at Ethicon Endo-Surgery, Cincinnati, Ohio) conducted by the authors. The standardization consisted of didactic training regarding the recommended patient population for inclusion in the study, detailed discussion of the protocol design, and review of the study

Results

Of 221 subjects who signed the informed consent document, 6 were removed from the analysis, 5 owing to entry criteria violations (3 subjects with missing baseline data,1 subject with a nonpalpable lesion, and 1 subject with a simple cyst). The sixth patient had a device failure and converted to an open biopsy procedure. Of the remaining evaluable study patients (n = 216), 127 women (59%) had the study procedure using the 8-gauge device and 89 women (41%) had procedures with the 11-gauge device.

Comments

Benign palpable lesions represent a group of breast masses that show well-defined clinical, physical, and radiographic characteristics for benign classification. These breast lesions commonly fluctuate in size with menses, are well circumscribed, and show defined characteristics on physical examination, mammography, and ultrasonography examination. Fibroadenomas are the most common masses found in women who are under 30 years of age. These benign tumors are characteristically painless,

Acknowledgements

Financial support was provided by Ethicon Endo-Surgery (Cincinnati, Ohio), who supplied the instruments used in this study, provided data analysis support, and assisted with presentation preparation.

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Citation Excerpt :
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Scientific paperLow-risk palpable breast masses removed using a vacuum-assisted hand-held device

Abstract

Background

Methods

Results

Conclusions

Section snippets

Methods

Results

Comments

Acknowledgements

Am J Surg

Am J Surg

The lifetime risk of developing breast cancer

J Natl Cancer Inst

Fibroadenoma of the breast

Med J Aust

US-guided automated large-core breast biopsy

Radiology

Ultrasound-guided core breast biopsyutility and cost-effectiveness

Radiology

Scientific paper
Low-risk palpable breast masses removed using a vacuum-assisted hand-held device